(281 days)
No
The summary describes a traditional ultrasonic surgical aspirator system and does not mention any AI or ML components or functionalities.
Yes.
The device is used for fragmentation, emulsification, precise breakage, aspiration, and debridement of tissues in various surgical procedures, which are considered therapeutic actions.
No
The device is described as an "ultrasonic surgical system" and "ultrasonic powered surgical tool" used for fragmentation, emulsification, aspiration, debridement, cutting, crushing, and shaping of tissue and bone. Its intended use is specified for various surgical procedures. There is no mention of the device being used to diagnose conditions or capture physiological information for diagnostic purposes.
No
The device description explicitly states that the system consists of a console, foot switch, and accessories including handpieces and tips, which are physical hardware components. The performance studies also include testing for electrical safety, EMC, sterilization, and acoustic performance, all related to hardware.
Based on the provided information, the XD880B Ultrasonic Surgical Aspirator System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- XD880B Function: The description clearly states the device is an ultrasonic surgical system used for the fragmentation, emulsification, cutting, crushing, shaping, aspiration, and debridement of tissues (soft and hard) within the body during surgical procedures.
- Intended Use: The intended uses listed are all surgical procedures performed directly on the patient's body.
- Device Description: The description focuses on the mechanical and ultrasonic functions of the device for tissue manipulation during surgery.
The device is a surgical tool used in vivo (within the living body), not for analyzing samples in vitro (outside the living body).
N/A
Intended Use / Indications for Use
The XD880B Ultrasonic Surgical Aspirator System is an ultrasonic surgical system consisting of handpieces and associated tips. The product is intended for the fragmentation, emulsification of both soft and hard (i.e. bone and bone approximations) tissue, the intended use is as follows with different configurations:
- · Neurosurgery
- · Gastrointestinal and Affiliated Organ Surgery
- · Urological surgery
- · Plastic and Reconstructive surgery
- · General Surgery
- · Orthopedic Surgery
- · Gynecological Surgery
- · Thoracic Surgery
- · Wound Care
- · Laparoscopic Surgery
- · Thoracoscopic Surgery
Product codes (comma separated list FDA assigned to the subject device)
LFL
Device Description
The XD880B Ultrasonic Surgical Aspirator System is an ultrasonic powered surgical tool. It can be used for precise breakage, aspiration and debridement of soft tissue, and can also be used for precise cutting, crushing and shaping of bone tissue. The product can be applied to a number of departments by using the suitable parameters and accessories, including:
- . Department of Neurosurgery, general surgery and other departments for soft tissue cutting, breakage and aspiration.
- . Department of Orthopedic surgery, Plastic and Reconstructive surgery, Department of Neurosurgery (only for bone) for bone cutting.
- . As well as the Department of Dermatology, Department of Trauma Orthopedics and other departments used for debridement.
The XD880B Ultrasonic Surgical Aspirator System consists of a console, foot switch, and accessories. The accessories include handpiece, tips, wrench, liquid-flow tube, sterilization tray, suction bag, suction canister and mobile cart. The handpiece, tips, liquid-flow tube are assembled into ultrasonic tool part to complete the cutting and fragment of bone tissue and soft tissues.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
To demonstrate safety and effectiveness of XD880B Ultrasonic Surgical Aspirator System and to show substantial equivalence to the predicate devices, SMTP Technology Co., Ltd. completed the following nonclinical tests. Results confirm that the design inputs and performance specifications for the device are met. The XD880B Ultrasonic Surgical Aspirator System passed the testing in accordance with internal requirements, national standards, and international standards shown below, supporting its safety and effectiveness, and its substantial equivalence to the predicate devices:
- Electrical safety testing per IEC 60601-1 - Passed
- . EMC testing per IEC 60601-1-2 - Passed
- . Software verification and validation per IEC 62304/FDA Guidance - Passed
- . Moist heat sterilization validation per ISO 17665-1- Passed
- EO sterilization validation per ISO 11135 - Passed, demonstrates SAL of 106
- Shelf-life Testing - Passed
- Lifetime validation test for handpieces - Passed
- . Acoustic Performance Test per IEC61847 - Passed
- . Efficiency and Temperature Characteristics Test - Passed
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 21, 2021
SMTP Technology Co., Ltd % Randy Jiang Sr. consultant Emergo Global Consulting, LLC 2500 Bee Cave Road, Building 1, Suite 300 Austin, Texas 78746
Re: K202299
Trade/Device Name: Ultrasonic Surgical Aspirator System Regulatory Class: Unclassified Product Code: LFL Dated: April 13, 2021 Received: April 19, 2021
Dear Randy Jiang:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdth/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements,
1
including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4. Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and. if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-howreport-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations. please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatorythe DICE website assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K202299
Device Name
Ultrasonic Surgical Aspirator System
Indications for Use (Describe)
The XD880B Ultrasonic Surgical Aspirator System is an ultrasonic surgical system consisting of handpieces and associated tips. The product is intended for the fragmentation, emulsification of both soft and hard (i.e. bone and bone approximations) tissue, the intended use is as follows with different configurations:
- · Neurosurgery
- · Gastrointestinal and Affiliated Organ Surgery
- · Urological surgery
- · Plastic and Reconstructive surgery
- · General Surgery
- · Orthopedic Surgery
- · Gynecological Surgery
- · Thoracic Surgery
- · Wound Care
- · Laparoscopic Surgery
- · Thoracoscopic Surgery
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| Prescription Use (Part 21 CFR 201 Subpart D) | Over-The-Counter Use (21 CFR 201 Subpart C) |
|---|---|
| ---------------------------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------- |
| X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
Ultrasonic Surgical Aspirator System
1. Submission Sponsor
SMTP Technology Co., Ltd. 1F&4F, Building A, Emerging Incubation Center, Zhangjiagang Free Trade Zone, Jiangsu Province, China. Contact: Songtao Zhan Title: CTO Phone number: +86-10-88572898
2. Submission Correspondent
Emergo Global Consulting, LLC 2500 Bee Cave Road Building 1, Suite 300 Austin, TX 78746 Office Phone: (512) 327-9997 Email: LST.AUS.ProjectManagement@ul.com Contact: Randy Jiang Title: Senior Consultant
3. Date Prepared
May, 19th, 2021
4. Device Identification
| Trade/Proprietary Name: | Ultrasonic Surgical Aspirator System |
|---|---|
| Common/Usual Name: | Ultrasonic Surgical Aspirator |
| Classification Name: | instrument, ultrasonic surgical |
| Regulation Number: | N/A, Pre-Amendment |
| Product Code: | LFL |
| Class: | Unclassified |
| Classification Panel: | General & Plastic Surgery |
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| K# | Name | Manufacturer | |
|---|---|---|---|
| Primary Predicate | |||
| Device | K070313 | Alliger Ultrasonic Surgical System | |
| Model AUSS-7 | Misonix Inc. | ||
| Secondary Predicate | |||
| Device | K062471 | FS 1000 RF Ultrasonic Surgical | |
| Aspirator System and Accessories | Misonix Inc. | ||
| Reference Device | K172464 | XD880A Ultrasonic Osteotomy | |
| Surgical System | SMTP Technology Co., Ltd |
5. Legally Marketed Predicate Device(s)
6. Indication for Use Statement
The XD880B Ultrasonic Surgical Aspirator System is an ultrasonic surgical system consisting of handpieces and associated tips. The product is intended for the fragmentation, emulsification and aspiration of both soft and hard (i.e. bone and bone approximations) tissue, the intended use is as follows with different configurations:
- Neurosurgery
- Gastrointestinal and Affiliated Organ Surgery
- Urological Surgery
- . Plastic and Reconstructive Surgery
- General Surgery
- Orthopedic Surgery
- . Gynecological Surgery
- Thoracic Surgery
- Wound Care
- . Laparoscopic Surgery
- Thoracoscopic Surgery
7. Device Description
The XD880B Ultrasonic Surgical Aspirator System is an ultrasonic powered surgical tool. It can be used for precise breakage, aspiration and debridement of soft tissue, and can also be used for precise cutting, crushing and shaping of bone tissue. The product can be applied to a number of departments by using the suitable parameters and accessories, including:
5
- . Department of Neurosurgery, general surgery and other departments for soft tissue cutting, breakage and aspiration.
- . Department of Orthopedic surgery, Plastic and Reconstructive surgery, Department of Neurosurgery (only for bone) for bone cutting.
- . As well as the Department of Dermatology, Department of Trauma Orthopedics and other departments used for debridement.
The XD880B Ultrasonic Surgical Aspirator System consists of a console, foot switch, and accessories. The accessories include handpiece, tips, wrench, liquid-flow tube, sterilization tray, suction bag, suction canister and mobile cart. The handpiece, tips, liquid-flow tube are assembled into ultrasonic tool part to complete the cutting and fragment of bone tissue and soft tissues.
8. Substantial Equivalence Discussion
The following Table 1 compares the Ultrasonic Surgical Aspirator System to the predicate devices with respect to intended use, power supply, product classification, irrigation system, and forms the basis for the determination of substantial equivalence. The subject device does not raise any new questions of safety or effectiveness as compared to the predicate devices.
| Attribute | Subject device | Primary Predicate Device
(K070313) | Secondary Predicate
Device (K062471) |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | SMTP Technology Co.,
Ltd. | Misonix Inc. | Misonix Inc. |
| Classification | Unclassified | Unclassified | Unclassified |
| Common/Usual
Name | Ultrasonic Surgical
Aspirator
Ultrasonic Surgical
System | Ultrasonic Surgical
Aspirator
Ultrasonic Surgical System | Ultrasonic Surgical
Aspirator
Ultrasonic Surgical
System |
| Regulation Panel | General & Plastic
Surgery | General & Plastic Surgery | General & Plastic Surgery |
| Product Code | LFL | LFL | LFL |
| Indications for
Use | The XD880B Ultrasonic
Surgical Aspirator
System is an ultrasonic
surgical system
consisting of | The Misonix Inc. AUSS-7
Ultrasonic Surgical System
is indicated for use in the
fragmentation and
aspiration of both soft and | The Misonix Inc. FS 1000
RE Ultrasonic Aspirator
System is indicated for
use in the fragmentation,
emulsification and |
| | handpieces and
associated tips. The
product is intended for
the fragmentation,
emulsification and
aspiration of both soft
and hard (i.e. bone and
bone approximations)
tissue, the intended
use is as follows with
different
configurations:
Neurosurgery Gastrointestinal
and Affiliated
Organ Surgery Urological Surgery Plastic and
Reconstructive
Surgery General Surgery Orthopedic
Surgery Gynecological
Surgery Thoracic Surgery Wound Care Laparoscopic
Surgery Thoracoscopic
Surgery | hard (e.g.: bone) tissue in
the following surgical
specialties:
Neurosurgery Gastrointestinal and
Affiliated Organ
Surgery Urological Surgery Plastic and
Reconstructive
Surgery General Surgery Orthopedic Surgery Gynecology Thoracic Surgery Wound Care | aspiration of both soft
and hard (i.e. bone)
tissue in the following
surgical specialties:
Neurosurgery Gastrointestinal and
Affiliated Organ
Surgery Urological Surgery Plastic and
Reconstructive
Surgery General Surgery Orthopedic Surgery Gynecological
Surgery Thoracic Surgery Laparoscopic
Surgery Thoracoscopic
Surgery The system may also be
combined with
electrosurgery using
optional RF Surgery
interface components. |
| Vibration System | Continuous Wave
Frequency:
39kHz & 52kHz | Continuous Wave
Frequency:
22.0-24.5 kHz | Continuous Wave
Frequency: 23+/-1 kHz or
22-24 kHz |
| Electrical Power
Supply | 100-240 VAC 50/60 Hz. | 100-130 VAC 6.5 Amps,
50/60 Hz
200/250 VAC 2.25 Amps,
50/60 Hz | 115 VAC and 230 VAC
50/60Hz |
| Power Input
Current | 3.6A max | 6.5A at 100-130 VAC,
3.25A at 200/250 VAC | 4A max |
| Footswitch | Foot switch connected
to the device control
unit by means of a
cord. | Wired (connected to rear
panel of console), Single
pedal footswitch to
activate delivery of
ultrasound and irrigation | Wired
- On/Off Pedal for
amplitude, irrigation and
aspiration - Flush Button - COAG with CUT lockout
feature - COAG simultaneous
with ultrasound - COAG only |
| Console | The functional
parameters are
displayed and
controlled through a
console with touch
screen. | Console with membrane
control panel and graphical
user interface | Console with membrane
control panel and LED
indicators. |
| Device contains
Software | Yes | Yes | Yes |
| Irrigation System | Peristaltic pump. | Peristaltic pump | Peristaltic pump |
| Irrigation fluid | Adjustable between:
5 to 120 ml/min. | Adjustable:
0 - 100 ml/min | Up to 10cc/min |
| Aspiration
Vacuum | 600mmHg (80kPa)
maximum | Max: 28" Hg Max | Min: less than 0.5" Hg
Max: 25" Hg |
| Dimensions | 18.0cm H × 31.0cm W ×
53.5cm D | 18.0cm H x 41.0cm W x
68.5cm D | 102cm H x 63.5cm W x
48cm D |
| Weight | 9.3kg | 11.6 kg | 54.5 kg |
Table 1 – Comparison of Characteristics
6
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9. Non-Clinical Performance Data
To demonstrate safety and effectiveness of XD880B Ultrasonic Surgical Aspirator System and to show substantial equivalence to the predicate devices, SMTP Technology Co., Ltd. completed the following nonclinical tests. Results confirm that the design inputs and performance specifications for the device are met. The XD880B Ultrasonic Surgical Aspirator System passed the testing in accordance with internal requirements, national standards, and international standards shown below, supporting its safety and effectiveness, and its substantial equivalence to the predicate devices:
8
- Electrical safety testing per IEC 60601-1 - Passed
- . EMC testing per IEC 60601-1-2 - Passed
- . Software verification and validation per IEC 62304/FDA Guidance - Passed
- . Moist heat sterilization validation per ISO 17665-1- Passed
- EO sterilization validation per ISO 11135 - Passed, demonstrates SAL of 106
- Shelf-life Testing - Passed
- Lifetime validation test for handpieces - Passed
- . Acoustic Performance Test per IEC61847 - Passed
- . Efficiency and Temperature Characteristics Test - Passed
10. Clinical Performance Data
Not applicable.
11. Statement of Substantial Equivalence
The XD880B Ultrasonic Surgical Aspirator System has the same intended use as the predicate devices, and the same or similar indications and technological characteristics. The differences do not raise new or different questions of safety and effectiveness. Electrical safety and performance testing have demonstrated the XD880B Ultrasonic Surgical Aspirator System is as safe and effective as the predicate devices. Therefore, the XD880B Ultrasonic Surgical Aspirator System is substantially equivalent to the predicate devices.